Low Dead-space Injecting Equipment Distribution Program for People Who Inject Drugs in Low- and Middle-income Countries

NCT06395129 | Recruiting DMC FDA Device

• 1 other identifier: HepC LDSS
• Study Type: observational
• Target: 2,400
• Locations: 3 countries
• Sites: 9

Brief Summary

Implementation and evaluation of a distribution program for low dead-space syringes/needles (LDSS/N) in Armenia, Georgia, and Tanzania, Egypt, Nigeria, Vietnam, India, Ukraine, and South Africa. This study aims to generate evidence on best practice LDSS/N distribution programs which will enhance acceptability and sustain high levels of LDSS/N uptake. People who inject drugs and access needle and syringe programs will be invited to attend up to three focus group discussion rounds (with 25 participants in each focus group round) to inform and provide feedback on a concurrent distribution program of LDSS/N. Throughout distribution, a cohort study will be run alongside distribution with 240 participants enrolled per country (with the exception of Nigeria, where 480 participants will be recruited) who will undergo HIV and HCV testing and answer surveys on their sociodemographic and behavioral status. Key informant interviews will also be held with participating staff and stakeholders to evaluate the feasibility and acceptability of this program. Primary outcomes assessed through this study include 1) community values and preferences for LDSS/N, 2) barriers and facilitators to accessing LDSS/N, 3) feasibility and effectiveness of the distribution program on increasing LDSS/N uptake, 4) model the potential public health impact and cost effectiveness of LDSS/N distribution in this setting.

Conditions

Drug Use; Hepatitis; Hiv

Keywords

Low dead-space needles and syringes; Qualitative interviews; LDSS/N; High dead space needles/syringes (HDSS/N); Rapid diagnostic test (RDT); Feasibility; Acceptability; Cost effectiveness; Modelling; Focus group discussions; Harm Reduction; Values and preferences; Needle and syringe exchange program; Blood borne virus

Outcome Measures

Primary Outcomes (1)

• Effectiveness of a community values and preferences informed LDSS/N distribution program on increasing LDSS uptake among people who inject drugs

  Defined as reported exclusive use of LDSS/N vs not exclusive use of LDSS/N

  18 months

Secondary Outcomes (7)

• Understanding community values and preferences for LDSS/N in the context of other harm reduction supplies available to people who inject drugs

  18 months

• Barriers and facilitators to access and uptake of LDSS/N among people who inject drugs

  18 months

• Differences in blood borne virus (HIV/HCV) incidence between those who exclusively use LDSS/N and those who do not

  18 months

• Model the potential public health impact (HCV and HIV infections averted) and cost-effectiveness of LDSS/N distribution for people who inject drugs within harm reduction settings

  18 months

• Identifying the enablers and challenges affecting the supply chain for LDSS/N

  18 months

Study Arms (1)

Cohort study

All participants in the cohort study will undergo surveys, HIV, and HCV testing at four possible timepoints (baseline, 6-months, 12-months, and if time permits 18-months). They will also have access to the study sites usual services, and the introduced LDSS/N.

Device: Low dead-space syringes/needles; Device: Hepatitis C Antibody Rapid Diagnostic Test; Device: HIV rapid Diagnostic Test

Interventions

Low dead-space syringes/needles DEVICE

LDSS/N are a type of syringe/needle which retains less residual blood following an injecting event when compared to HDSS/N.

Also known as: LDSS/N

Cohort study

Hepatitis C Antibody Rapid Diagnostic Test DEVICE

Administered up to 4 times, at baseline, 6-months, 12-months, and 18-months

Also known as: HCV RDT

Cohort study

HIV rapid Diagnostic Test DEVICE

Administered up to 4 times, at baseline, 6-months, 12-months, and 18-months

Also known as: HIV RDT

Cohort study

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Study sites will set a target for participation among women in line with the percentage of women accessing needle/syringe programmed locally. Where data is not currently available on gender, or if attendance is very low, the investigators will aim to recruit a minimum quota of 15% to ensure meaningful participation among women.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

People aged 18+ who report injecting drug use

You may qualify if:

• Aged ≥18 years (note that country-specific protocols may include participants aged ≥16 where appropriate and relevant);
• Reporting a history of recent (past month) injection drug use;
• Accessing the NSP to receive injecting equipment at either a facility, mobile service or through outreach and have an accompanying assigned program unique ID;
• Able to understand and communicate in the local language(s);
• If self-reporting HCV/HIV negative status, interested in and agreeing to undergo HCV and HIV testing; and
• Willing and able to provide informed consent to take part in the study.

You may not qualify if:

• N/A

Sponsors & Collaborators

• Médecins du Monde: lead
• UNITAID: collaborator
• Burnet Institute: collaborator
• International Network of People who Use Drugs: collaborator
• University of Bristol: collaborator
• Frontline AIDS: collaborator
• Caritas: collaborator
• Drug-free and preventitve healthcare organisation Nigeria: collaborator
• National Viral Hepatitis and STI Control Program Nigeria: collaborator
• PATH: collaborator
• Population Services International: collaborator
• London School of Hygiene and Tropical Medicine: collaborator

Study Sites (9)

Real World Real People

Yerevan, Armenia

RECRUITING

Step to Future

Gori, Georgia

RECRUITING

New Vector

Rustavi, Georgia

RECRUITING

Hepa+

Tbilisi, Georgia

RECRUITING

Mukikute

Dar es Salaam, Tanzania

RECRUITING

Peer 2 Peer

Dar es Salaam, Tanzania

RECRUITING

Yovaribe

Ilala, Tanzania

RECRUITING

Mefada

Kinondoni, Tanzania

RECRUITING

STEPS Tanzania

Ubungo, Tanzania

RECRUITING

MeSH Terms

Conditions

Hepatitis; Acquired Immunodeficiency Syndrome; Harm Reduction

Interventions

Needles

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Behavior

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Officials

• Mark Stoové

  Burnet

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bridget Draper

CONTACT

+61 413 272 698; bridget.draper@burnet.edu.au

Mark Stoové

CONTACT

mark.stoove@burnet.edu.au

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2024
• First Posted: May 1, 2024
• Study Start: September 13, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: October 1, 2025

Record last verified: 2025-09

Locations

AR (1); TA (5); GE (3)